MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-08 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[46792091]
It was reported that the ire generator (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation. To date, the generator has yet to be returned. Attempts are being made to obtain the unit. An investigation into the root cause for the event is currently in process. A review of the device history records was performed for the serial number (b)(4). The review confirms that the unit met all material, assembly, and performance specifications. The results of the unit evaluation will be sent via a follow up medwatch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46792092]
As reported may 31, 2016, a (b)(6), male patient presented for an ire (irreversible electroporation) procedure of the liver. During the procedure, the accusync displayed a saturation signal. This is a signal the patient experienced an episode of ventricular extrasystoles the 3 cables were replaced and the procedure was successfully completed. It was reported that the patient suffered no adverse effects due to the event. It was reported the nanoknife system is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2016-00093 |
| MDR Report Key | 5706119 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-31 |
| Date of Event | 2016-05-26 |
| Date Mfgr Received | 2016-05-31 |
| Date Added to Maude | 2016-06-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION DEVICE |
| Product Code | OAB |
| Date Received | 2016-06-08 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-08 |